Ansaizhu (pertuzumab biosimilar) / Qilu Pharma - LARVOL DELTA

Multiomic factor analysis for pathologic complete response after pembrolizumab + trastuzumab + pertuzumab in HER2-enriched early breast cancer: WSG-Keyriched-1 trial. (PubMed, Clin Cancer Res) - "Our multiomic analysis uncovered mechanisms of tumor response to immunotherapy combined with dual HER2 blockade. These results could inform the design of larger trials investigating chemotherapy-free regimens in selected patients with HER2+ eBC."

IO biomarker • Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • CD36 • HER-2 • MYCN • PGR • SCARB1

A phase I, randomized, double-blind, parallel, single-dose pharmacokinetic study to evaluate the biosimilarity of KM118 (proposed pertuzumab biosimilar) with reference pertuzumab (Perjeta®) in healthy male subjects. (PubMed, Ann Med) - P1 | "Both formulations were well tolerated. chinaDrugtrials.org.cn, identifier CTR20202566 (December 17, 2020); chictr.org.cn, identifier ChiCTR2400092982 (November 26, 2024)."

Clinical • Journal • PK/PD data

A Study of QLS1209 in theTreatment of Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=149 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1 trial • Oncology • Solid Tumor

Chia Tai Tianqing's "pertuzumab" biosimilar was approved for marketing [Google translation] (bydrug.pharmcube.com) - "On December 23, the official website of the National Medical Products Administration (NMPA) showed that the marketing application of Chia Tai Tianqing pertuzumab injection has been approved for the treatment of breast cancer....There are also a number of domestic companies in the layout of pertuzumab biosimilars, among which Qilu Pharmaceutical's pertuzumab biosimilars were also approved for marketing today..."

China approval • Breast Cancer

QL1209 (pertuzumab biosimilar) versus reference pertuzumab plus trastuzumab and docetaxel in neoadjuvant treatment for HER2-positive, ER/PR-negative, early or locally advanced breast cancer: A multicenter, randomized, double-blinded, parallel-controlled, phase III equivalence trial. (PubMed, Br J Cancer) - P3 | "QL1209 demonstrated equivalent efficacy and comparable safety profile to the reference pertuzumab in neoadjuvant treatment of HER2-positive, ER/PR-negative, early, or locally advanced breast cancer."

Clinical • Journal • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive and Estrogen Receptor/Progesterone Receptor Negative Breast Cancer to Evaluate the Efficiency and Safety of Treatment With Trastuzumab Plus (+) QL1209/Pertuzumab + Docetaxel. (clinicaltrials.gov) - P3 | N=517 | Completed | Sponsor: Qilu Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Oct 2023

Combination therapy • Metastases • Trial completion • Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Neoadjuvant QL1209 (a pertuzumab biosimilar) compared with pertuzumab plus trastuzumab and docetaxel in early or locally advanced, HER2-positive, ER(-)/PR(-) breast cancer: A multicenter, randomized, double-blind, equivalence, phase III study (ESMO 2023) - P3 | "Incidences of ADA and Nab were similar between 2 groups (2.3% vs 3.1%; 0.8% vs 0.8%). Table: 245P Conclusions QL1209 demonstrated equivalence to P in efficacy and showed comparable safety profile and immunogenicity in patients with early or locally advanced HER2-positive breast cancer."

Clinical • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2

Qilu Pharmaceutical to Showcase Novel Anti-Cancer Drug QL1706 at ESMO Congress 2023 (PRNewswire) - "Data from Qilu Pharmaceutical's clinical trial of its novel bifunctional antibody, QL1706 (iparomlimab and tuvonralimab), will be unveiled during a mini oral presentation at the European Society for Medical Oncology (ESMO) Annual Congress 2023...The presentation will provide updates on a multicenter, single-arm phase II clinical trial of QL1706. This innovative treatment, used in combination with chemotherapy and with or without bevacizumab, is being investigated for its potential as a first-line therapy for recurrent or metastatic cervical cancer (CC)....Additionally, a poster showcasing a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial conducted by Qilu Pharmaceutical. This study examines the use of a combination of pertuzumab biosimilar (QL1209), trastuzumab and docetaxel as a neoadjuvant therapy for the treatment of early or locally advanced HER2-positive, hormone receptor-negative breast cancer will be featured at the congress."

P2 data • P3 data • Breast Cancer • Cervical Cancer • Gynecologic Cancers • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor

A randomized, double-blind, parallel control study to evaluate the biosimilarity of QL1209 with Perjeta in healthy male subjects. (PubMed, Front Pharmacol) - "The incidence of drug-related adverse events was 95.6% and 95.5% in the QL1209 and Perjeta groups, respectively, also comparable between the two groups. The results of this comparative clinical pharmacology study demonstrated the PK similarity of QL1209 (420 mg: 14 ml) and Perjeta (420 mg: 14 ml) and there was no significant difference in safety and immunogenicity between QL1209 and Perjeta manufactured by Roche Pharma AG."

Clinical • Journal

Rare ocular toxicity induced by pertuzumab/QL1209 in healthy chinese subjects: case reports and whole-exome sequencing analysis. (PubMed, Invest New Drugs) - "In summary, this is the first report describing the occurrence of ocular toxicity induced by pertuzumab in the Chinese population and exploring the possible genetic mechanisms. These findings could provide evidence for clinicians to raise concerns about the risk of ocular toxicity with the clinical use of pertuzumab."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Ophthalmology • Solid Tumor • IRS2 • mTOR